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Neuroprosthetic Device
Neuroprosthetic System for Spinal Cord Injury (NNP-UE+T Trial)
N/A
Recruiting
Research Sponsored by Kevin Kilgore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 16 years
Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord Injury (INCSCI) motor level of C4 through C8; American Spinal Injury Impairment Scale (AIS) grade A, B, C, or D; six months or more post-injury
Must not have
Unhealed fractures that prevent functional use of arm or trunk
Active untreated infection such as decubitus ulcer, urinary tract infection, pneumonia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-implant and three months post-implant
Awards & highlights
No Placebo-Only Group
Summary
This trial is to test a new, fully implanted device that could help people with cervical spinal cord injuries regain hand function, reach, and trunk function. It is funded by the FDA, NIH, and NINDS.
Who is the study for?
This trial is for individuals over 16 years old with cervical spinal cord injuries (C4-C8 level, AIS grade A-D) who are at least six months post-injury. Participants must have some arm and trunk muscle strength, be medically stable for surgery, and willing to participate. Pregnant women, those with certain neurological conditions or severe diseases, active infections, or other implantable devices are excluded.
What is being tested?
The study tests a fully implanted neuroprosthetic system designed to restore hand function, reach ability, and trunk control in people with cervical spinal cord injuries. It aims to evaluate the device's effectiveness in improving motor functions that were affected by the injury.
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include surgical complications like infection or bleeding; device malfunction; discomfort; adverse reactions from the body towards the implant; and possible interference with other electronic devices.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 16 years.
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I have a spinal cord injury at the neck level and it's been over 6 months since the injury.
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My arm and trunk muscles respond well to stimulation.
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I can move my arm and some upper body muscles with some strength.
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I can move my arm against gravity.
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I am medically cleared for surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have fractures that stop me from using my arm or body properly.
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I currently have an untreated infection like a skin ulcer, UTI, or pneumonia.
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I have a neurological condition like multiple sclerosis or diabetes affecting my nerves.
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I do not have severe heart, lung, blood clotting disorders, HIV, or severe slow heart rate.
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I have significant nerve damage in my upper limbs.
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My spinal cord injury is getting worse and I am getting implants on both sides.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three months post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months post-implant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Activities of Daily Living Abilities Test
Secondary study objectives
Grasp-Release Test
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention - implant neuroprosthesisExperimental Treatment1 Intervention
Receives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment.
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,385 Previous Clinical Trials
652,658 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
57 Previous Clinical Trials
10,443 Total Patients Enrolled
Case Western Reserve UniversityOTHER
309 Previous Clinical Trials
251,229 Total Patients Enrolled
FDA Orphan Products DivisionUNKNOWN
Kevin KilgoreLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 16 years.I have a spinal cord injury at the neck level and it's been over 6 months since the injury.My arm and trunk muscles respond well to stimulation.I can move my arm and some upper body muscles with some strength.You have other implanted medical devices that might not work well with the new implant.You have a pacemaker or defibrillator, unless there are specific exceptions.I have fractures that stop me from using my arm or body properly.I have a neurological condition like multiple sclerosis or diabetes affecting my nerves.I do not have severe heart, lung, blood clotting disorders, HIV, or severe slow heart rate.I currently have an untreated infection like a skin ulcer, UTI, or pneumonia.I can move my arm against gravity.I am medically cleared for surgery.I have significant nerve damage in my upper limbs.My spinal cord injury is getting worse and I am getting implants on both sides.You need to use a machine to help you breathe.You have a condition that needs to be monitored with MRI scans.Your medical devices could be affected by common electronic devices in your home and work.It has been less than 6 months since my injury.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention - implant neuroprosthesis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT02329652 — N/A